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Hyperglycaemia and teen drivers with type 1 diabetes

The effect of blood glucose levels on driving behaviour and executive functioning in teenagers with type 1 diabetes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001321639
Enrollment
35
Registered
2014-12-17
Start date
2014-12-07
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project aims to investigate the effect of hyperglycaemia (high blood glucose levels) on executive functioning, and higher-level driving skills in young people with Type 1 diabetes. We hypothesise that acute hyperglycaemia will have a negative effect on participants performance on tests of executive functions and safe driving skills in young people with Type 1 diabetes compared to performance when blood glucose level is within the target range.

Interventions

Participants’ performance on executive function and driving assessments will be assessed under euglycaemic and hyperglycaemic conditions. These will be compared to determine how blood glucose levels affect executive function and high level driving skills. The order of the assessment sessions will be randomised. One assessment will be when the participant has a blood glucose level between 4 mmol/L – 9.4 mmol/L (euglycaemic) and the second when the participant has a blood glucose level above 15 m

Participants’ performance on executive function and driving assessments will be assessed under euglycaemic and hyperglycaemic conditions. These will be compared to determine how blood glucose levels affect executive function and high level driving skills. The order of the assessment sessions will be randomised. One assessment will be when the participant has a blood glucose level between 4 mmol/L – 9.4 mmol/L (euglycaemic) and the second when the participant has a blood glucose level above 15 mmol/L (hyperglycaemic). Each assessment will take approximately two hours. There will be a break of approximately two weeks between assessment sessions. To increase a participants blood glucose to the hyperglycaemic range they will be given a standardised carbohydrate snack. Participants will be administered an insulin dose based on their Insulin Sensitivity Factor calculation to lower their blood glucose level to the euglycaemic range. During both assessments, participants will complete objective executive functioning tasks and computer based driving tasks. Assessment of general cognitive ability, subjective ratings of executive functioning and driving behaviour will be completed when participants BGL is within the euglycaemic range At the completion of the Hyperglycaemic session, the participants will be administered an insulin dose to lower blood glucose level to euglycaemic range using the participant’s Insulin Sensitivity Factor calculation.

Sponsors

Waikato Regional Diabetes Service, Waikato DHB
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to 19 Years
Healthy volunteers
No

Inclusion criteria

1. Aged between 16 and 19 years 2. Diagnosis of Type 1 Diabetes (longer than 6 months) 3. Hold a restricted or full New Zealand driver licence 4. Drive regularly (> 4 times per week)

Exclusion criteria

1. Pregnancy 2. Regular use of illicit substances 3. Episode of Diabetic Ketoacidosis in the previous 48 hours 4. Episode of documented severe hypoglycaemia requiring assistance in the previous 24 hours

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026